In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, PRIM&R Executive Director Elisa Hurley explores the complex issue of clinical trial data sharing and its implications for the protection of human research subjects.
Though not a new issue, clinical trial data sharing has over the past several months taken center stage within the medical research community. In December 2015, a STAT [...] Read more
By Jason Gerson, PhD
The Patient-Centered Outcomes Research Institute (PCORI) supports research that provides high-integrity, evidence-based information to patients, clinicians, and the broader healthcare community. PCORI funds clinical comparative effectiveness research (CER) that engages patients and other stakeholders throughout the research process. The research we fund aspires to answer real-world questions about what works best for patients, based on their circumstances and concerns.
From PCORI’s start, supporting methodological research has been a priority; it is highlighted as such in our authorizing legislation. We think broadly about what [...] Read more
This week’s Research Ethics Roundup explores ClinicalTrials.gov transparency issues, a potentially controversial citywide study of a new procedure for gunshot and stabbing victims in Philadelphia, charges against an Indian drug developer accused of fraudulent research, and a rebuttal to researchers who have resisted including female mice and rats in pain research. Read more
On July 12, 2016, PRIM&R hosted a webinar titled Navigating the New Reliance Agreement Landscape, presented by Tracy Ziolek, MS, CIP, and Emily Chi Fogler, Esq. This webinar highlighted the necessity for institutional review boards (IRBs) to adapt to new requirements related to multi-site research. Read more
Among several seminal moments in the field of research ethics, Henry K. Beecher’s 1966 paper, “Ethics and Clinical Research” stands out for its breadth and scope. In what has come to be known in the field as Beecher’s Bombshell, the paper reported on 22 prominent studies that contained serious ethical issues; the impact of the “bombshell” has been felt throughout the field ever since. Read more
Building a Culture of Research was the theme of a panel session sponsored by the National Council of University Research Administrators (NCURA) that kicked off the 2016 Maine Regulatory Training and Ethics Center (MeRTEC) Research Integrity and Regulatory Compliance Symposium, held in Portland, Maine, on May 19 and 20. Joseph Tomaras, Director of Sponsored Programs and Research Compliance at Bates College, presented Focusing on your Organization: Coalition‐Building and Change Management in Building a Culture of Research. Cara Martin-Tetreault provided a different perspective in her presentation, Focusing on Yourself: Professional Development and Organizational Learning in Creating a Culture of Research. Together, these talks went beyond regulatory compliance and best practices to offer a unique perspective on creating a supportive and effective research culture. Read more